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A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic Disorders

Primary Purpose

Eosinophilic Esophagitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fluticasone Propionate
Sponsored by
Marc Rothenberg
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis focused on measuring Eosinophilic Esophagitis

Eligibility Criteria

3 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed informed consent for study by parent or guardian. Assent will be obtained from all minors 11 years of age and older. Age older than or equal to 3 years and younger than or equal to 30 years Endoscopic findings consistent with EE (edema, furrowing, exudates, rings) Histological findings to include proliferation of basal layer and peak eosinophil density ≥24 per high power field (400x). This degree of tissue eosinophilia has been shown to correlate well with poor-responsiveness to acid suppression therapy, suggesting it is a primary eosinophilic disease and not secondary to GERD[11]. Allergy evaluation including skin-prick testing with multiple food antigens to insure elimination diet is not indicated. If allergic to specific foods, option to be on a minimum 3 months of elimination diet without detectable resolution by repeat endoscopy with biopsies demonstrating no improvement to disease. Patients enrolled at CCHMC will be under the direct care of Dr. Putnam or any of the other staff gastroenterologists at this institution who will supervise endoscopic procedures. Patients may also be enrolled at institutions other than CCHMC, but the diagnosis of EE must be validated by an expert pathologist in EE at CCHMC (Margaret Collins, MD). 20 additional patients without EE will be enrolled as unaffected controls for purposes of comparison with patients with EE. Enrollment pool will comprise patients undergoing routine upper endoscopy and having no identifiable pathology. Exclusion Criteria: Patients with history of poor tolerance to FP, patients unable to cooperate with use of MDI, pregnant females, patients inhaling any corticosteroid for asthma, and patients with concurrent or recent (within 3 months) use of systemic steroids.

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Outcomes

Primary Outcome Measures

Histologic remission
Histologic remission,defined by a peak eosinophil count of less than/equal to 1 eosinophil in all 400 fields in both the proximal and distal esophagus.

Secondary Outcome Measures

Furrowing, Epithelial hyperplasia, clinical symptoms
Secondary outcome measures included presence of endoscopic furrowing, presence of epithelial hyperplasia, and presence of clinical symptoms.

Full Information

First Posted
December 15, 2005
Last Updated
April 10, 2013
Sponsor
Marc Rothenberg
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1. Study Identification

Unique Protocol Identification Number
NCT00266578
Brief Title
A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic Disorders
Official Title
Effect of Swallowed Fluticasone Propionate on Eosinophilic Esophagitis; A Prospective, Randomized, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marc Rothenberg

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is assessing the efficacy of swallowed Flovent® vs. placebo for the treatment of eosinophilic esophagitis (EE).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
Eosinophilic Esophagitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate
Intervention Description
Flovent vs. placebo daily for 3 months
Primary Outcome Measure Information:
Title
Histologic remission
Description
Histologic remission,defined by a peak eosinophil count of less than/equal to 1 eosinophil in all 400 fields in both the proximal and distal esophagus.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Furrowing, Epithelial hyperplasia, clinical symptoms
Description
Secondary outcome measures included presence of endoscopic furrowing, presence of epithelial hyperplasia, and presence of clinical symptoms.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent for study by parent or guardian. Assent will be obtained from all minors 11 years of age and older. Age older than or equal to 3 years and younger than or equal to 30 years Endoscopic findings consistent with EE (edema, furrowing, exudates, rings) Histological findings to include proliferation of basal layer and peak eosinophil density ≥24 per high power field (400x). This degree of tissue eosinophilia has been shown to correlate well with poor-responsiveness to acid suppression therapy, suggesting it is a primary eosinophilic disease and not secondary to GERD[11]. Allergy evaluation including skin-prick testing with multiple food antigens to insure elimination diet is not indicated. If allergic to specific foods, option to be on a minimum 3 months of elimination diet without detectable resolution by repeat endoscopy with biopsies demonstrating no improvement to disease. Patients enrolled at CCHMC will be under the direct care of Dr. Putnam or any of the other staff gastroenterologists at this institution who will supervise endoscopic procedures. Patients may also be enrolled at institutions other than CCHMC, but the diagnosis of EE must be validated by an expert pathologist in EE at CCHMC (Margaret Collins, MD). 20 additional patients without EE will be enrolled as unaffected controls for purposes of comparison with patients with EE. Enrollment pool will comprise patients undergoing routine upper endoscopy and having no identifiable pathology. Exclusion Criteria: Patients with history of poor tolerance to FP, patients unable to cooperate with use of MDI, pregnant females, patients inhaling any corticosteroid for asthma, and patients with concurrent or recent (within 3 months) use of systemic steroids.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc E. Rothenberg, M.D., Ph.D.
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States

12. IPD Sharing Statement

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A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic Disorders

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